Identity
- Trade Name
- LED DayLite REVEAL FC EUDAMEDLED Daylite REVEAL FDA UDI
- Generic Name
- Fluorescence wound imaging unit FDA UDI
- Device Name
- LED DayLite REVEAL FC EUDAMEDThe REVEAL FC is indicated for use as a wound autofluorescence imaging device to view autofluorescence images from skin wounds that are exposed to its excitation light. FDA UDI
- Model / Reference
- 9500-0000-0000 EUDAMEDFDA UDI
- Description
- The REVEAL FC is indicated for use as a wound autofluorescence imaging device to view autofluorescence images from skin wounds that are exposed to its excitation light. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810070572600 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007057LED19TS EUDAMED
- FDA Product Code
- QCR FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Fluorescence wound imaging unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4165 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Fluorescence wound imaging unit
LED Daylite REVEAL by Designs for Vision, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Fluorescence wound imaging unit.
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- SnapshotGLO — Kent Imaging Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Designs for Vision, Inc.
Sources (2)
- FDA UDI 4937dea9-03db-485d-ba73-5659ffce11c0 34 fields · synced Jun 19, 2026
- EUDAMED 7942cb03-626d-465f-8b20-64f758a56bf2 61 fields · synced Jun 19, 2026